Prostate Cancer Advances: Erleada Combo, Novartis Actinium Drug, Bayer-Kairos Collaboration

New data from a late-stage trial showed that combining Johnson & Johnson's Erleada (apalutamide) with hormone-blocking therapy significantly improved outcomes in patients with high-risk localized prostate cancer undergoing surgery. The regimen, administered six months before and after surgery, increased the likelihood of eliminating cancer and reduced the risk of disease progression or death. The findings were presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago, where additional prostate cancer updates were also disclosed.

In the trial, patients receiving the combination were nine times more likely to have minimal or no detectable cancer in the prostate at surgery, with 8.9% achieving that result versus 1% of those on hormone therapy alone. The addition of Erleada reduced the risk of cancer spreading or causing death by 20%. In a separate group that received a full year of Erleada plus hormone therapy around surgery, men went on average more than six years before requiring subsequent treatment, nearly doubling the time seen with hormone therapy alone, and the extended regimen reduced the risk of recurrence and death by 29%. Approximately 40% of the 330,000 people diagnosed with prostate cancer in the U.S. each year are classified as high-risk, and nearly half of patients who undergo standard prostate-removal surgery and radiation experience a return of their cancer. The trial enrolled more than 2,000 patients with high-risk localized or locally advanced prostate cancer who were candidates for prostate gland removal. "No ARPIs are approved for localized high-risk prostate cancer with either surgery or radiation," said the study's lead researcher, describing the data as "paradigm-changing." Erleada, an androgen receptor pathway inhibitor, received U.S. approval in 2018 and is used with hormone therapy. The company plans to work with regulators to secure global approval for the combination in earlier-stage disease. The safety profile was consistent with previous studies; common side effects included hot flushes, urinary incontinence, and erectile dysfunction.

At the same meeting, Novartis presented data from a 101-patient study of an experimental actinium-225-based radioligand therapy. Among patients previously treated with Pluvicto, 52.5% saw PSA levels fall by at least half. More than 85% of patients with no prior treatment and 58.8% of those who received chemotherapy first had PSA reductions of at least 50%. The experimental drug uses actinium-225, an alpha emitter, while Pluvicto uses lutetium-177, a beta emitter. "The difference is that much higher amounts of energy are delivered across a much smaller distance, and the potential for greater efficacy," a Novartis executive said. Novartis is advancing two late-stage studies of the drug. Radioligand therapies now account for nearly 40% of the company's cancer R&D investments. Novartis already sells Pluvicto and Lutathera, which brought in a combined $2.8 billion last year. In February, the company entered a long-term supply agreement for actinium with U.S.-based medical isotope producer Niowave.

Separately, Bayer and Kairos Pharma are collaborating to study Kairos' lead antibody ENV-105 (carotuximab) in combination with Bayer's Xofigo (radium-223 dichloride) in metastatic castration-resistant prostate cancer (mCRPC) involving bone. ENV-105 is a first-in-class CD105/BMP signaling inhibitor; CD105 is a protein driving resistance and relapse in response to standard cancer therapy. In preclinical models, ENV-105 has shown radiation sensitization in prostate cancer, and targeting CD105 may re-sensitize resistant tumors, extending the duration and depth of response to Xofigo. Kairos' ENV-105 program includes a Phase II trial in CRPC that showed positive interim efficacy data in 2025, as well as a Phase I trial in EGFR-driven non-small cell lung cancer. Xofigo is the first and only FDA-approved alpha-emitting radiopharmaceutical for mCRPC with symptomatic bone metastases, and is also being studied in combinations, including a Phase III trial that showed a 24% reduction in mortality risk when combined with enzalutamide. "Drug resistance remains one of the greatest challenges in advanced prostate cancer," the Kairos Pharma CEO said, noting that Xofigo, like many standard-of-care therapies, can lose efficacy over time.